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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): February 26, 2025
SHUTTLE
PHARMACEUTICALS HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41488 |
|
82-5089826 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
401
Professional Drive, Suite 260
Gaithersburg,
MD 20879
(Address
of principal executive offices) (Zip Code)
(240)
430-4212
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common Stock $0.00001 per
share |
|
SHPH |
|
The Nasdaq Stock Market
LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
2.02 Results of Operations and Financial Condition.
On
February 26, 2025, Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company”), issued a press
release providing a corporate update in connection with the filing of its Annual Report on Form 10-K for the year ended December 31,
2024.
A
copy of the press release is attached as Exhibit 99.1 hereto and incorporated herein by reference.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that Section. Such information may be incorporated by reference in another filing under the Exchange Act or the
Securities Act of 1933, as amended, only if and to the extent that such subsequent filing specifically references such information.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
SHUTTLE PHARMACEUTICALS HOLDINGS, INC. |
|
|
|
Dated:
February 26, 2025 |
|
|
|
|
|
|
By: |
/s/
Anatoly Dritschilo |
|
Name: |
Anatoly Dritschilo |
|
Title: |
Chief Executive Officer |
Exhibit
10.1
Shuttle
Pharma Provides Corporate Update and Reports 2024 Results
GAITHERSBURG,
Md., February 26, 2025 — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”),
a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation
therapy (RT), today provided a corporate update in connection with the filing of its Annual Report on Form 10-K for the year ended December
31, 2024.
Shuttle
Pharma’s recent highlights include the following:
| ● | Accelerated
patient enrollment of the Company’s key Phase 2 clinical trial of Ropidoxuridine for
treatment of patients with glioblastoma with 40% enrollment in the initial randomized
portion. As of today, a total of 17 of the initial 40 patients have been enrolled,
with 8 of the 17 patients having completed all seven cycles. |
| ● | The
Phase 2 trial is being conducted at nationally recognized cancer centers, including Georgetown
University Medical Center, Allegheny Health Network (AHN) Cancer Institute, UNC Medical Center,
the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center,
and Miami Cancer Institute, part of Baptist Health South Florida. |
| ● | Continued
advancement of the Company’s Diagnostics subsidiary through the entry of a sponsored
research agreement with the University of California, San Francisco (UCSF) to advance pre-clinical
development of a ligand to the prostate-specific membrane antigen (PSMA) as a potential diagnostic
and therapeutic, or theranostic, molecule. Theranostic molecules are suitable for diagnosis
and therapy of cancers. |
| ● | Launched
new corporate website highlighting Shuttle Pharma’s dual approach to Cancer Therapeutics
and Diagnostics. Visit https://shuttlepharma.com/ to learn more about how Shuttle
Pharma is developing novel therapies designed to increase cancer cure rates, prolong patient
survival, and improve quality of life. |
| ● | Management
has made significant investments into the business, including the Company’s Chief Executive
Officer, Dr. Anatoly Dritschilo, providing $237,500 along with other investors in a recent
financing transaction. |
“This
past year has been highlighted by numerous scientific developments, led by the commencement of our Phase 2 clinical trial of Ropidoxuridine
for treatment of patients with glioblastoma,” stated Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “We
are more than one-third complete with the initial randomized portion of enrollment with a target to complete enrollment in the coming
year. This clinical trial is critical to the broader radiation therapy industry as we look to leverage radiation sensitizers to increase
cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”
“We
have also made significant progress to advance our diagnostic subsidiary, Shuttle Diagnostics, where our approach is to offer prognosis
and guide treatment decisions, with the goal of providing clinicians and patients with a means of measuring the potential for success
of radiation therapy for their cancer treatment. Through the development of a PC-Rad test for predicting outcomes following radiation
therapy for localized prostate cancer, and a PSMA-B ligand, a theranostic molecule offering diagnosis and therapeutics for metastatic
prostate cancer, we offer a completely new way to predict success for a specific treatment.”
“2025
is set to be a year of scientific milestones. I look forward to the continued progress made as we aim to improve the lives of millions
impacted by cancer and bring hope to patients and families around the world,” Dr. Dritschilo concluded.
About
Shuttle Pharmaceuticals
Founded
in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty
pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve
the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects
of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim
to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination
with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com.
Safe
Harbor Statement
Statements
in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not
historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements
concerning the development of our company. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar expressions are
intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual
results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including
factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ended December
31, 2024, filed with the SEC on February 26, 2025, as well other SEC filings. Any forward-looking statements contained in this
press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically
disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Shuttle
Pharmaceuticals
Anatoly
Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com
Investor
Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com
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